Rapid Treatment of PTSD With Accelerated Non-Invasive Brain Stimulation

Part of paid clinical trials in Tallahassee, Florida.

Sponsor
Florida State University
Study ID
NCT06544408
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Cool B70 AP Coil - Active (dl-PFC) — DEVICE
    One side of the coil is the active and the other is sham. The B70 AP coil will be positioned over the left dorsolateral prefrontal cortex (dl-PFC).
  • Cool B70 AP Coil- Sham (dl-PFC) — DEVICE
    One side of the coil is the active and the other is sham. The B70 AP coil will be positioned over the left dorsolateral prefrontal cortex (dl-PFC).
  • Cool D-B80 AP Coil - Active (dm-PFC) — DEVICE
    One side of the coil is the active and the other is sham. The cool D-B80 AP coil will be positioned over the midline (bilateral) dorsal medial prefrontal cortex (dmPFC) using location 25.8% distance from nasion to inion.
  • Cool D-B80 AP Coil - Sham (dm-PFC) — DEVICE
    One side of the coil is the active and the other is sham. The cool D-B80 AP coil will be positioned over the midline (bilateral) dorsal medial prefrontal cortex (dmPFC) using location 25.8% distance from nasion to inion.
  • Cool B70 Treatment Coil - Active Only — DEVICE
    The treatment will be the same as the left dl-PFC accel-TMS dl-PFC except that the Cool B70 Treatment coil only has an active treatment coil.

Study Details

This study will test the clinical efficacy of an accelerated TMS (accel-TMS) protocol that rapidly addresses PTSD symptoms with 1 week (25 sessions over 5 days) of condensed treatment.

Key Dates

Start date
Nov 6, 2024
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Dec 30, 2028

Study Design

Enrollment
132 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Arm 1: active left dl-PFC accel-TMS
    Acute Phase: Eligible participants will be randomized into one of the three treatment groups: active left dl-PFC accel-TMS vs. active dm-PFC accel-TMS vs. sham dl-PFC/dm-PFC accel TMS
  • Active Comparator: Arm 2:active dm-PFC accel-TMS
    Acute Phase: Eligible participants will be randomized into one of the three treatment groups: active left dl-PFC accel-TMS vs. active dm-PFC accel-TMS vs. sham dl-PFC/dm-PFC accel TMS
  • Sham Comparator: Arm 3 - sham accel-TMS dl-PFC
    Acute Phase: Eligible participants will be randomized into one of the three treatment groups: active left dl-PFC accel-TMS vs. active dm-PFC accel-TMS vs. sham dl-PFC/dm-PFC accel TMS
  • Sham Comparator: Arm 4: sham accel -TMS dm-PFC
    Acute Phase: Eligible participants will be randomized into one of the three treatment groups: active left dl-PFC accel-TMS vs. active dm-PFC accel-TMS vs. sham dl-PFC/dm-PFC accel TMS
  • Active Comparator: Arm 5
    Extension phase, all participants will receive active left dl-PFC accel-TMS.

Primary Outcome Measure

Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine left dl-PFC accel-TMS efficacy [ Time Frame: Assessment of symptoms during the preceding week. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Florida State UniversityTallahasseeFlorida32306
Isabelle M Taylor, MA
[email protected]
850-644-2824
Kevin A Johnson, PhD
[email protected]
850-644-2824
Frank A Kozel, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tallahassee, FL

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Florida State University· Tallahassee, FL

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